Real-world post-authorization effectiveness study (PAES) of pembrolizumab for the treatment of NSCLC across races, ethnicities, and age groups (MK-3475-G18)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  KEYTRUDA
• Study drug International non-proprietary name (INN) or common name:
  PEMBROLIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01FF02) pembrolizumab

  pembrolizumab
• Medical condition to be studied:
  Non-small cell lung cancer

Population studied

• Short description of the study population:
  Adult patients diagnosed with non-small cell lung cancer (NSCLC) and treated with pembrolizumab (monotherapy or in combination with platinum-based chemotherapy [PBC]) between the eligibility October 2, 2015 and June 30, 2025 in the US will be eligible for inclusion in this study.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  10000

Study design details

• Study design:
  This retrospective cohort study will be conducted using the Flatiron Health US-based deidentified electronic health record databases to characterize the real-world effectiveness of pembrolizumab for the treatment of non-small cell lung cancer (NSCLC) across races, ethnicities, and age groups.
• Main study objective:
  The main objective of this study is to evaluate the real-world effectiveness of pembrolizumab monotherapy and pembrolizumab in combination with platinum-based chemotherapy (PBC) in United States (US)-based NSCLC patients by estimating real-world overall survival (rwOS) among the following subgroups: Race (racial minorities [e.g., Black or African American, Asian, American Indian/Alaska Native, Native Hawaiian/Other Pacific Islander, and Other Race] and white patients), Hispanic/Latino ethnicity (Hispanic/Latino patients and not Hispanic/Latino patients), and Age (elderly patients ≥75 years and younger patients <75 years).;
• Setting:
  This retrospective cohort study will be conducted using the Flatiron Health US-based deidentified electronic health record (EHR)-derived databases: early non-small cell lung cancer (eNSCLC) Flatiron Health Research Database (FHRD), and advanced non-small cell lung cancer (aNSCLC) FHRD. ; The study will include adult patients diagnosed with NSCLC and treated with pembrolizumab (monotherapy or in combination with PBC) between October 2, 2015 and June 30, 2025.;
• Outcomes:
  The primary outcome of interest for the current study will be death, as measured by rwOS, defined as the time from pembrolizumab treatment start to date of death. ; Patients without a date of death will be censored on the date of the last follow-up or data cutoff date, whichever occurs first.
• Data analysis plan:
  Real-world overall survival will be estimated using Kaplan-Meier methods for each of the following subgroups: race (racial minorities, white), ethnicity (Hispanic/Latino, not Hispanic/Latino), and age group (elderly, younger). ; Median survival times and the probabilities of survival at key milestones of interest (e.g., 1-year, 2-year) and corresponding 95% confidence intervals will be calculated. ; These methods will be used to describe estimates of real-world overall survival for each subgroup.;